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Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Combined treatment of medial knee osteoarthritis

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
Moderately active
Varus knee alignment equal or superior to 2°

Exclusion Criteria:

Severe knee OA (K-L grade IV)
Rheumatoid arthritis or other inflammatory arthritis
Avascular necrosis
History of periarticular fracture or septic arthritis
Bone metabolic disease
Pigmented villonodular synovitis
Cartilaginous disease
Neuropathic arthropathy
Synovial osteochondromatosis
Total or partial knee arthroplasty
Flexion contracture of ipsi- or contra-lateral knee greater than 15°
Hip or ankle joint damage with mobility limitation
Obesity (BMI ≥ 40)
Intra-articular corticosteroids injection in the affected knee during the two previous months
Reduced mobility (Charnley class C)

Sites / Locations

Pavillon de l'Éducation Physique et des Sports - Université Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Lateral customized foot orthoses

Knee brace

Combination of the two treatments

Arm Description

Foot orthoses with arch support and lateral inclination set at 7° (alone)

OdrA Knee brace (alone)

Combination of Lateral customized foot orthoses and knee brace

Outcomes

Primary Outcome Measures

Change in Knee adduction moment

Change in Knee pain

A 20-cm visual analog scale (0-100) is used to assess pain.

Secondary Outcome Measures

Change in Spatiotemporal gait parameters

Change in Knee adduction angle

Change in Comfort

A 20-cm visual analog scale (0-100) is used to assess comfort.

Full Information

NCT ID

NCT01870336

First Posted

May 23, 2013

Last Updated

March 3, 2016

Sponsor

Laval University

Collaborators

Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01870336

Brief Title

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

Official Title

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laval University

Collaborators

Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lateral customized foot orthoses

Arm Type

Experimental

Arm Description

Foot orthoses with arch support and lateral inclination set at 7° (alone)

Arm Title

Knee brace

Arm Type

Experimental

Arm Description

OdrA Knee brace (alone)

Arm Title

Combination of the two treatments

Arm Type

Experimental

Arm Description

Combination of Lateral customized foot orthoses and knee brace

Intervention Type

Device

Intervention Name(s)

Combined treatment of medial knee osteoarthritis

Primary Outcome Measure Information:

Title

Change in Knee adduction moment

Time Frame